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Drug Safety Evaluation 1st Edition by Shayne Cox Gad ISBN 0471407275 9780471407270

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Drug Safety Evaluation 1st Edition Shayne Cox Gad Digital Instant Download

Author(s): Shayne Cox Gad
ISBN(s): 9780471407270, 0471407275
Edition: 1
File Details: PDF, 5.82 MB
Year: 2002
Language: english
SKU: EB-921918 Category: Tag:

Drug Safety Evaluation 1st Edition by Shayne Cox Gad – Ebook PDF Instant Download/Delivery: 0471407275, 9780471407270

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Product details:

ISBN 10: 0471407275 

ISBN 13: 9780471407270

Author: Shayne Cox Gad

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated.

Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including:

  • Acute toxicity testing in pharmaceutical safety evaluation
  • Genotoxicity
  • Safety assessment of inhalant drugs
  • Immunotoxicology in pharmaceutical development
  • Large animal studies
  • Evaluation of human tolerance and safety in clinical trials

Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

Table of contents:

CHAPTER 1: Drug Development Process and Global Pharmaceutical Marketplace
CHAPTER 2: Regulation of Human Pharmaceutical Safety
CHAPTER 3: Prior Art and Its Use in Safety Assessment Process
CHAPTER 4: Screens in Safety and Hazard Assessment
CHAPTER 5: Formulations, Routes, and Dosage Design
CHAPTER 6: Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation
CHAPTER 7: Genotoxicity
CHAPTER 8: Repeat-Dose Toxicity Studies
CHAPTER 9: Immunotoxicology in Drug Development
CHAPTER 10: Nonrodent Animal Studies
CHAPTER 11: Developmental and Reproductive Toxicity Testing
CHAPTER 12: Carcinogenicity Studies
CHAPTER 13: Histopathology in Nonclinical Pharmaceutical Safety Assessment
CHAPTER 14: Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment
CHAPTER 15: Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation
CHAPTER 16: Safety Pharmacology
CHAPTER 17: Special Concerns for Preclinical Evaluation of Biotechnology Products
CHAPTER 18: Safety Assessment of Inhalant and Dermal Route Drugs
CHAPTER 19: Special-Case Products: Imaging Agents and Oncology Drugs
CHAPTER 20: Occupational Toxicology in Pharmaceutical Industry
CHAPTER 21: Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals
CHAPTER 22: Application of In Vitro Techniques in Drug Safety Assessment
CHAPTER 23: Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond
CHAPTER 24: Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses
CHAPTER 25: Statistics in Pharmaceutical Safety Assessment
CHAPTER 26: Combination Products: Drugs and Devices
CHAPTER 27: Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals

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Tags: Shayne Cox Gad, Drug Safety, Evaluation